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Not yet recruitingNCT07546162Updated Sep 10, 2026

Development and Clinical Validation of Key Technologies for Non-invasive Breath Metabolic Fingerprinting for Large-scale Population Lipid Screening

An observational study in Hyperlipidemia, sponsored by Beijing Anzhen Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Beijing Anzhen Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
18 Years and older
Sex
All
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Study summary

This study collects exhaled breath condensate samples from healthy populations and hyperlipidemic populations, analyzes the characteristics of the exhaled metabolic lipid profile for early identification of people with abnormal blood lipids, verifies the feasibility and accuracy of a new gas detection method for screening abnormal blood lipids, and explores a simple, fast, and non-invasive method for screening abnormal blood lipids.

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Conditions studied

  • Hyperlipidemia

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy population, population with hyperlipidemia

Inclusion criteria

  1. Age ≥ 18 years
  2. Voluntarily sign the informed consent form

Exclusion criteria

Exclusion Criteria:

  1. Patients with lung cancer, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or acute respiratory distress syndrome
  2. Women during pregnancy or breastfeeding
  3. Patients with chronic kidney disease (GFR \<60 ml/min) or liver cirrhosis
  4. Individuals unable to cooperate in collecting exhaled breath samples
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hyperlipidemia

    Diagnostic Test: Lipid Abnormality Mass Spectrometry Screening Model

Interventions

  • Diagnostic testLipid Abnormality Mass Spectrometry Screening Model

    By analyzing the lipid profile in human breath, explore a simple, fast, and non-invasive method for screening dyslipidemia

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What researchers measure

Primary outcomes

  1. Sensitivity , specificity , Receiver Operating Characteristic Curve and Area Under Curve of mass spectrometry screening model for dyslipidemia

    Time frame: Week1

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07546162
Lead sponsor
Beijing Anzhen Hospital
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Sep 14, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 10, 2026

Study contacts

Yan Yan
Contact
eva3321@sina.com
+861064456782

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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